Method of reconfiguring a mitral valve annulus

ABSTRACT

Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal or transapical navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The size and/or shape of the implant may then be adjusted, pulling mitral annulus tissue radially inwardly, and restrained in the adjusted configuration to improve mitral valve function.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 14/562,554, filed Dec. 5, 2014, which claims the prioritybenefit under 35 U.S.C. §119(e) of U.S. Provisional Application No.62/025,967, filed Jul. 17, 2014, and U.S. Provisional Application No.62/038,032, filed Aug. 15, 2014, the entireties of which are herebyincorporated by reference herein.

BACKGROUND

1. Field

The present application relates generally to treating heart disease, andmore specifically, to methods and systems for an adjustable endolumenalmitral valve ring.

2. Description of Related Art

Heart disease can cause the chambers of the heart to expand and/orweaken. With specific reference to the mitral valve of the heart, whenthe left ventricle dilates, papillary muscles become displaced. When themitral valve is incompetent due to heart disease, the mitral annulus(e.g., the annulus of the mitral valve) dilates excessively. In thisstate of dilation, the valve leaflets of the mitral valve no longereffectively close, or coapt, during systolic contraction. Consequently,regurgitation of blood occurs during ventricular contraction and cardiacoutput decreases.

This condition is typically addressed by open-heart surgicalimplantation of an annuloplasty ring. Typically, a surgeon positions anannuloplasty ring proximate to the mitral annulus and sutures it inplace, thereby restoring the mitral valve to approximately its nativecircumference. If successful, the valve leaflets can then functionnormally again.

However, open-heart surgery is not without its shortcomings. Openheart-surgery is highly invasive and has many associated risks,including risks of infection, heart attack and/or stroke, memory loss,blood clots, blood loss, injury to the surrounding anatomy, and/or manyother pains and/or discomforts. Accordingly, there is a need in the artfor less invasive systems and methods for addressing heart valveincompetency of the mitral valve.

SUMMARY

The present disclosure includes methods and systems relating toreshaping a mitral valve using a laser-cut tubular implant having aplurality of struts with barbed anchors for tissue engagement. Theimplant may be compressible to a first, reduced diameter fortransluminal navigation and delivery to the mitral valve treatment site.It may then be expandable to a second, enlarged diameter for engagingtissue surrounding and/or including the mitral valve (as used herein,the tissue surrounding and/or including the mitral valve includes themitral annulus). Typically, the anchors of the implant embed into thetissue while the implant is in the enlarged state. The implant may thencontract to a third, intermediate diameter, pulling the tissue of themitral valve radially inward, which reduces the mitral valve. Thereduction of the mitral valve may lessen any of the symptoms associatedwith excessive mitral valve dilation, including mitral regurgitation.Any or all of the expanding or contracting functions can be accomplishedeither actively or passively.

In one implementation of the invention, there is provided a method ofreconfiguring a mitral valve annulus. The method comprises positioningan implant having a first diameter into a left atrium, the implantcomprising a frame having a proximal end, a distal end, a pair of strutsjoined at an apex, and a plurality of anchors near the distal end. Thepositioned implant is expanded to a second diameter larger than thefirst diameter, and the expanded implant is connected to tissuesurrounding a mitral valve by embedding the plurality of anchors intothe tissue. An angle between the pair of struts is adjusted to contractthe implant, and a restraint is positioned on the pair of struts toretain the angle. The connecting step may comprise distally advancingthe anchors relative to the frame. The connecting step may compriserotating the anchors. The adjusting step may comprise reducing an anglebetween the pair of struts, and may comprise axially moving therestraint relative to the pair of struts. The adjusting step maycomprise rotating the restraint. The positioning a restraint step maycomprise retaining the angle by positioning a collar around the pair ofstruts to prevent the angle between the pair of struts from increasing.

The positioning a collar step may comprise rotating the collar inthreaded engagement with the frame, and may comprise axially distallymoving the restraint relative to the pair of struts. The adjusting stepmay change the size and/or shape of the implant. The anchors may moveaxially relative to the frame in response to rotation, and may comprisea helical configuration which embeds into tissue in response torotation.

The positioning step may be accomplished via a femoral artery access,brachial artery access, jugular vein access, or transapical access.

In some embodiments, the implant may be delivered to the tissuesurrounding and/or including the mitral valve using a delivery system.The delivery system may comprise of a delivery catheter connected to theimplant. The delivery catheter may have a handle that can manipulate thedelivery catheter and the implant. Typically, the delivery of theimplant may be performed under fluoroscopic and/or echo guidance.

The delivery system may use a sheath to cover the implant for deliveryand a guidewire to advance and steer the delivery catheter into positionwith the implant at the distal end. The implant may be exposed bypulling the sheath back. Once exposed and delivered, the anchors of theimplant may be embedded into the tissue surrounding and/or including themitral valve. In some embodiments, the anchors of the implant may beretractable and/or helical-shaped. In some cases, the anchors may engagethe tissue by pushing, pulling, and/or rotating the anchors.

The implant size and/or shape may then be changed by a number ofadjustment mechanisms, including mechanisms that use nuts, clips, and/orcables. Some mechanisms serve as restraints to adjustably change thedistance between two or more anchors on the implant, such as through aworking range, and ultimately affect the size and/or shape of a valveannulus, such as the mitral valve annulus. The adjustment of thesemechanisms may be performed by using rotational drivers and/or actuatorsat the proximal end of the handle of the delivery catheter. Therotational drivers and/or actuators may be used to compress or expandthe implant at the operator's discretion to adjust the final size and/orshape of the implant (and hence, the mitral valve) as desired. Thedelivery system may be disconnected and removed once the implant hasbeen delivered and adjusted as desired, and/or once mitral regurgitationhas been reduced or eliminated. The implant may be left as a permanentimplant.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings, provided to illustrate and not to limit thedisclosed aspects, wherein like designations denote like elements.

FIG. 1A illustrates an example heart showing the left ventricle and theleft atrium along with associated anatomical landmarks.

FIG. 1B illustrates a top-down view of the mitral valve of the exampleheart illustrated in FIG. 1A.

FIGS. 2A-2E illustrate example ways for introducing a delivery catheterto the mitral valve.

FIG. 3 illustrates a transapical entry through the left ventricle andmitral valve using a delivery catheter having a guidewire.

FIG. 4 illustrates an example exposed and/or unsheathed implant at theend of the delivery catheter of FIG. 3.

FIG. 5A illustrates the example implant of FIG. 4 in an expanded state.

FIG. 5B illustrates the example implant of FIG. 5A embedded in thetissue surrounding and/or including the mitral valve.

FIGS. 6A-L illustrate example structural details of various embodimentsof the implant illustrated FIG. 5A-B.

FIG. 7 illustrates an example tilt adjuster that may be used with thedelivery catheter illustrated in FIG. 5A.

FIG. 8 illustrates an example tapered implant with a diamond pattern.

FIG. 9 illustrates an example retractable anchor mechanism that may beused in some implants.

FIG. 10 illustrates an example anchor being removed from an anchor coveror sheath.

FIG. 11 illustrates the expanded shape of an example implant from a topand side view.

FIG. 12 illustrates an example implant where the amplitude isnonsymmetrical about the implant's diameter.

FIG. 13 illustrates an example hook-and-wire rotational driver that canbe used to manipulate an implant.

FIG. 14 illustrates an example two-arm rotational driver that is similarto the rotational driver of FIG. 13.

FIG. 15 illustrates an example hex rotational driver that can be used tomanipulate an implant.

FIGS. 16A-B illustrate a side-view and top-view of a rotational driverthat can be used to rotate a nut over a strut in an appropriatedirection.

FIGS. 17A-B illustrate an example push-slider mechanism that may be usedto manipulate an implant.

FIG. 18A illustrates an example delivery system for an implant havingforward (distal) facing anchors for entry from the left atrium, or forentry from a femoral vein and a transseptal puncture.

FIG. 18B illustrates an example delivery system for an implant havingproximal facing anchors for entry from a left ventricle (e.g., atransapical entry).

FIG. 19 illustrates a close-up of an example implant with proximalfacing anchors with screw-and-clip mechanisms to adjust the shape and/orsize of the implant.

FIG. 20 illustrates a close-up of the implant of FIG. 19 where thescrew-and clip mechanisms reduce the diameter of the implant.

FIG. 21 illustrates a close-up of an example implant with distal facinganchors and screw-and-clip mechanisms to adjust the shape and/or size ofthe implant.

FIG. 22A illustrates a close-up of an example implant with proximalfacing anchors and connection arms connected to the implant.

FIG. 22B illustrates an example implant with proximal facing anchors andconnection arms attaching the implant to a delivery system.

FIG. 23 illustrates example anchor configurations of various shapes.

FIG. 24 illustrates an example implant with anchors covered withslideable elements.

FIG. 25 illustrates the example implant from FIG. 24 with anchorsexposed and ready for implantation.

FIGS. 26A-C illustrate an example anchor that has a helical shape thatcan be rotated through an extension of an implant strut to engage thetissue surrounding and/or including a mitral valve.

FIG. 27 illustrates an example anchor that has a helical shape that canbe rotated through an implant strut to engage the tissue surroundingand/or including a mitral valve.

FIG. 28 illustrates an example implant with anchors that have a helicalshape.

FIG. 29 illustrates the example implant of FIG. 28 in an expanded state.

FIG. 30 illustrates the example implant of FIG. 29 where the anchorshave been extended.

FIG. 31 illustrates the example implant of FIG. 30 where the exampleimplant has been contracted.

FIG. 32 illustrates an example replacement prosthetic heart valveoperably coupled to an example implant.

DETAILED DESCRIPTION

This disclosure encompasses all changes, substitutions, variations,alterations, and modifications to the example embodiments herein that aperson having ordinary skill in the art would comprehend. Similarly,where appropriate, the appended claims encompass all changes,substitutions, variations, alterations, and modifications to the exampleembodiments herein that a person having ordinary skill in the art wouldcomprehend. Moreover, reference in the appended claims to an apparatusor system or a component of an apparatus or system being adapted to,arranged to, capable of, configured to, enabled to, operable to, oroperative to perform a particular function encompasses that apparatus,system, component, whether or not it or that particular function isactivated, turned on, or unlocked, as long as that apparatus, system, orcomponent is so adapted, arranged, capable, configured, enabled,operable, or operative. For example, various embodiments may performall, some, or none of the steps described above. Various embodiments mayalso perform the functions described in various orders.

Although the present invention has been described herein in connectionwith several embodiments; changes, substitutions, variations,alterations, transformations, and modifications may be suggested to oneskilled in the art, and it is intended that the present inventionencompass such changes, substitutions, variations, alterations,transformations, and modifications as falling within the spirit andscope of the appended claims.

FIG. 1A illustrates an example heart showing the left ventricle and theleft atrium along with associated anatomical landmarks. Left atrium 102receives oxygenated blood from the pulmonary veins (e.g., pulmonary vein106). When left atrium 102 contracts, mitral valve 104 opens and bloodleaves left atrium 102 through mitral valve 104 into left ventricle 105.When left ventricle 105 contracts, mitral valve 104 closes and aorticvalve 103 opens. Blood then flows into aorta 101, which carries bloodaway from heart 100 to the rest of the body.

FIG. 1B illustrates a top-down view of the mitral valve of the exampleheart illustrated in FIG. 1A. Mitral valve 104 has two leaflets,anterior leaflet 120 and posterior leaflet 124. Anterior leaflet 120 islocated proximal to aorta 121, and comprises of segments A1, A2, and A3.Posterior leaflet 124 is located distal to aorta 121, and comprises ofscallops P1, P2, and P3. Scallops P1, P2, and P3 are extensions alongthe line of closure that allow the leaflets to accommodate the curvedshape of the valve. Anterior leaflet 120 and posterior leaflet 124 cometogether at anterolateral commissure 123 and posteromedial commissure122.

Mitral valve incompetence may occur when mitral valve 104 does not closeproperly when heart 100 pumps out blood. This can lead to bloodregurgitating left ventricle 105 (FIG. 1A) back into left atrium 102when left ventricle 105 contracts. The regurgitation may lead tosymptoms including dyspnea, fatigue, orthopnea, and/or pulmonary edema.

FIGS. 2A-2E illustrate example ways for introducing a delivery catheterto the mitral valve. FIG. 2A illustrates various common points of entryfor a delivery catheter to access heart 100 of person 250. Deliverycatheters may be used for delivering materials to a location of thebody, including drugs, therapeutic treatments (e.g., energy forablation), diagnostics, and/or implants. Typically, a delivery catheterhas a long, flexible tubular portion that may be inserted into thelumens of arteries or veins. A person having ordinary skill in the artshould appreciate that there are any number of entry points and/or waysthat a delivery catheter may be inserted into the body. A few examplesare described herein for illustration. A delivery catheter may beinserted into heart 100 percutaneously or through a cut-down procedurethrough the right or left femoral artery from point 252 or 256 in thelegs and/or groin. A delivery catheter may also be inserted into heart100 through the brachial arteries from points 254 and 253 in the arms.Another common entry point for a delivery catheter may be point 255 inthe neck, which allows the catheter to be inserted into the jugularvein.

Once inserted into the body, FIG. 2B further illustrates common entrypoints for introducing a delivery catheter to mitral valve 104 of heart100. Included are transseptal entry 202, transatrial entry 201, andtransapical entry 203, which will be discussed in more detail.

FIG. 2C illustrates an example transseptal entry. Delivery catheter 211may be introduced to right ventricle 215 through a venous entry in theleg and/or groin. Delivery catheter 211 may then pass to left atrium 102through transseptal puncture 212 in order to reach mitral valve 104.

FIG. 2D illustrates an example transatrial entry. Delivery catheter 220is introduced to heart 100 through puncture 221 in the wall of leftatrium 102 to mitral valve 104. From left atrium 102, delivery catheter220 may reach mitral valve 104.

FIG. 2E illustrates an example transapical entry. Delivery catheter 231is introduced through the apex of the heart through puncture 232 intoleft ventricle 105. From there, delivery catheter 231 may reach mitralvalve 104 and left atrium 102.

There may be additional paths for reaching mitral valve 104. Forexample, a delivery catheter may reach mitral valve 104 throughpulmonary vein 106. A delivery catheter may also use a transaorticentry. Embodiments of the present invention are not limited to anyparticular way of gaining access to the mitral valve. A person havingordinary skill in the art should appreciate that the methods and systemsof this disclosure are not limited to any particular path(s) and may bereadily adaptable to others not specifically described. However, theaforementioned entry points are a few illustrative examples of howembodiments of this disclosure may be introduced to mitral valve 104.

FIG. 3 illustrates a transapical entry through the left ventricle andmitral valve using a delivery catheter having a guidewire. Guidewire 306may guide delivery catheter 301 into left ventricle 105 through puncture232 at the apex of heart 100. From left ventricle 105, guidewire 306 mayfurther guide delivery catheter 301 into left atrium 102 through mitralvalve 104.

The implant (not pictured) may be carried in a compressed state at thedistal end of delivery catheter 301 and housed in sheath 308, which canbe an outer tubular jacket, during initial navigation. Such compressionmay be desirable in order to advance the implant in situ for positioningin the body via arterial or venous entry without having the implantinteract with arterial or venous tissue, and/or any other tissue of thebody before being delivered to left atrium 102.

The size of delivery catheter 301 may be, for example, generally withinthe range of about 10 to about 35 French in diameter, but may typicallybe about 24 French. Delivery catheter 301 may have a catheter length ofabout 45 to 100 centimeters in some embodiments. The proximal end ofdelivery catheter 301 may include a handle for operator interface andcontrol. The handle may allow the implant, guidewire 306, and/ordelivery catheter 301 to be manipulated within the body by curving tip307 and angling the delivery catheter for accurate positioning.Alternatively, through axial, distal, and/or proximal advancement of oneor more control wires or cables, tip 307 of delivery catheter 301 can betensioned and/or deflected to alter the shape of the distal end ofdelivery catheter 301. Tip 307 may also be rotationally repositioned tomatch the anatomical needs for the target valve area or position.Guidewire 306 may pass through delivery catheter 301 and extend throughtip 307. Guidewire 306 may aid in the navigation of delivery catheter301. Guidewire 306 may measure, in some cases, from about 0.014 inchesto 0.035 inches in diameter, but in some cases, the larger 0.035 inch indiameter may be preferable.

FIG. 4 illustrates an example exposed and/or unsheathed implant 400 atthe end of the delivery catheter of FIG. 3. Implant 400 may be exposedand/or unsheathed by pulling back sheath 308 covering it, oralternatively pushing the implant distally past the sheath 308 in otherembodiments. The covered state was illustrated in FIG. 3. Connectionarms 401 run through delivery catheter 301 to implant 400 and allow fortranslation of forces for adjusting implant 400 and/or moving it aroundfor positioning. These movements may include translational, rotational,and/or angular adjustments from the handle of delivery catheter 301.Connection arms 401 and delivery catheter 301 can be separated fromimplant 400, leaving the implant engaged in the heart after delivery andimplantation.

Any implant of this disclosure (e.g., implant 400) may be constructedfrom, for example, metallic materials and/or polymers with sufficientstructural integrity to reshape a mitral valve. The material may also bechosen based on biocompatility and fatigue resistance. Implantmaterial(s) could include stainless steel, Nickel-Titanium,Cobalt-Chromium, Pyrolytic Carbon, Nitinol, polymer materials (e.g.,PEEK), and/or other suitable implant materials. In some cases, theimplant may also be coated with drug-eluting material to preventfibrosis and/or clotting.

The implant may be laser cut from a tubular member to form the basicshape. The implant may also be heat-set into a shape for furtherassembly, which may include the further steps of electrochemical etchingand/or a secondary polishing to remove irregular and/or unwantedmaterial. These further steps may be used to smoothen the surface of theimplant. Alternatively, the implant could be formed from a wire that isfused together by a laser. The implant may generally comprise of aplurality of, for example sinusoidal strut elements joined at proximaland distal apexes to create a zigzag pattern. In some embodiments, theimplant may comprise a frame comprising a plurality of struts connectedto a plurality of anchors near the ends of the struts. The frame of theimplant may include a central lumen therethrough. The struts may alsoform a diamond-shaped pattern similar to an expanded Palmaz coronarystent, or the strut arms could have a flat plateaued segmenttherebetween at the apex in some cases. In other words, the apicesshould have a sharp edge, a curved edge, or a flat top among othergeometries. The implant could be configured to multiple shapes and sizesduring processing, including its initial laser-cut, tubular shape andsize, and a heat-set shape and size for further processing (e.g.,polishing and assembling). The implant may have a central lumentherethrough.

In some embodiments, the initial tube from which the implant is cut mayhave an outside diameter that could vary from 4 to 10 millimeters indiameter, however, a diameter of about 8 millimeters could be used inmost cases. The initial tube wall thickness may be about 0.008 to about0.040 inches, but could typically be about 0.020 inches. The laser-cutimplant with a sinusoidal shape may have an axial length of about 10 to40 millimeters. In some cases, an axial length of about 20 millimetersmay be used. The implant may have, for example, between 4 to 32 strutelements, however, typically 8 to 16 struts may be used.

The configuration of the laser-cut pattern could have a connecteddiamond pattern and/or a sinusoidal or other geometry with a pluralityof integral or separately formed anchors comprising barbs and/or hooksto engage heart tissue for securement and/or permanent fixation. Theanchors may extend distally from some and/or all of the struts and/orfrom the apexes of the struts. The anchors may be adapted to engage adilated mitral annulus, and may be contractible either actively orpassively with the implant, as will later be discussed. The anchorscould also be internally or externally mounted to the implant allowingthem to be covered or retracted during delivery and/or positioning. Fortissue engagement, the anchors may utilize a single barbed element or aplurality of barbed elements.

Additionally, the barbed elements of each anchor could be of similarlengths and orientations, or various lengths and orientations dependingupon the implant area tissue and surrounding sensitivity to tissueengagement. Additionally, the barbs could match the tubular shape of theas-cube tube, or be formed secondarily in and/or out of the tubularsurface plane, which may angle the barb portion out of the cylindricalshape.

The implant could comprise one or more sinusoidal struts having eightcurved apexes with eight anchors to engage the tissue at the distal endof the implant, where the anchors measure about 3 to 4 millimeters inlength with 1, 2, 3, 4, or more barbs per anchor in some cases. Theanchors may be further processed by twisting and/or rotating theanchors, their hooks, and/or their barbs after laser cutting. Suchtwisting and rotating may create more complex shapes (e.g., helical,tortious, and/or amorphous shapes) for improved tissue attachment insome cases.

The implant may be delivered in a first diameter and/or configuration,wherein the first diameter allows the implant to be carried within thesheath of the delivery catheter. In some cases, the implant may expandto a second diameter and/or configuration (e.g., by the retraction ofthe sheath and/or other mechanisms described in this disclosure), whichwould allow the implant to be expanded for positioning. Once desirablypositioned, the implant could be attached by intimate tissue contactand/or force either longitudinally or radially outward. In some cases,such attachment would be performed by engaging the anchors of theimplant to tissue surrounding and/or including the mitral valve. Theimplant may change size and/or shape to a third diameter and/orconfiguration after tissue engagement in order to change the shape ofthe mitral valve. The third diameter may be a reduced diameter incomparison to the second diameter, and could ease mitral regurgitationby pulling the tissue surrounding and/or including the mitral valvecloser together, thereby reducing the mitral valve. Adjustments could bemade to the implant by mechanisms coupled to the delivery catheter'shandle located exterior to the patient.

Changes to the third diameter may be used to alter the geometry of themitral valve area and its surrounding tissue. The natural opening of themitral valve may not be a perfectly circular shape, but may be shapedmore like a saddle with amplitude and ovality. Therefore, the finalthird diameter may not be perfectly circular, but may be more ellipticaland/or amorphous with some customization required depending upon thepatient's anatomy and the nature of the valvular incompetency. Thiscustomization can be achieved through selectively modifying the implantshape to better reduce the regurgitant flow through the patient's mitralvalve. Echo imaging and/or fluoroscopy may indicate the desirable valvecooptation. The customization may include selectively and independentlyaltering the sinusoidal element angles of the implant. For example, ifthe arms of one or more struts of the implant were moved closer to oneanother, the anchors connected to the arms of the one or more strutswould also be moved closer to one another, which would move the mitraltissue attached to each anchor closer together. Numerous examplemechanisms for such movements will be described in this disclosure.

As an example, the implant may be constructed from a Nitinol tubingmeasuring about 8 millimeters in diameter and laser-cut into a patternallowing for expansion and heat-setting. The implant height could beabout 10 to 30 millimeters and could vary around the perimeter to matchthe saddle shape of the mitral valve. The laser cut patterns include asinusoidal or diamond shape allowing for the implant to be reduced tothe first diameter of about 5-8 millimeters for loading into a deliverycatheter. The implant may be expanded to a second diameter of about 25to 50 millimeters for implantation into the tissue surrounding and/orincluding a mitral valve. The third diameter may be from about 20 to 25millimeters to set the diameter of the mitral valve. The implant couldbe heat set into a round and/or cylindrical shape with tapering at thetop and/or bottom to match the anatomical location. Accurate imaging bymeans of fluoroscopy and/or ultrasound imaging or other conventionalimaging tools to view surrounding tissue and the implant deliveryplacement is typical and could be used for implantation and/oradjustment.

As will be described, for delivery, the implant may be connected to adelivery catheter by a plurality of receiver holes formed as part of thestruts of the implant. The receiver holes may be designed to mate with aplurality of connection arms (e.g., connection arms 401) connected tothe delivery catheter. The receiver holes can be an integral part of theimplant structure or a secondary structure coupled to the implant thatmay or may not be implanted. The connection arms may have radialflexibility allowing the implant to expand to various diameters. Theconnection arms may join the implant to the delivery catheter and tiltthe implant by lengthening and shortening the connection arms onopposing sides via handle adjustment. Such tilting may be induced foranatomical positioning and/or angular adjustments. The ability to tiltthe implant before engaging the anatomy compensates for patientanatomical variability. In some embodiments, tilting can vary from minus30 degrees to plus 30 degrees at any selected angle. Alternatively, thedelivery catheter may be pre-shaped with a fixed angle to accommodateanatomical irregularities and/or variations from patient-to-patient.This angular adjustment could also occur through delivery catheter angleadjustments at the distal end through cable tensioning or bending of thedistal end of the catheter to influence the angle.

FIG. 5A illustrates the example implant of FIG. 4 in an expanded state.This expansion could be activated with a force generated from the handleof delivery catheter 301 through the use of connection arms 401 and/orexpandable members such as balloons (e.g., a balloon disposed withinimplant 400 and/or disposed within connection arms 401) to expandimplant 400 to a desired diameter. The expansion could be uniform and/orcircular, an elliptical shape, and/or amorphously shaped to match theanatomy of mitral valve 104. The expansion could also be tailored tomatch the patient's specific anatomical needs if an irregular shape weredesirable. Once the implant is expanded, the protruding anchors ofimplant 400 may be embedded in the tissue surrounding and/or includingthe mitral valve by pulling or pushing implant 400, and/or any othermechanism described in this disclosure.

FIG. 5B illustrates the example implant of FIG. 5A embedded in thetissue surrounding and/or including the mitral valve. Accordingly,implant 400 may be positioned so that it and mitral valve 104 may bereduced in diameter and/or dimension as desired. In some cases, thereduction of implant 400, and consequently mitral valve 104, could beachieved by passive forces through the hysteresis of the material ofimplant 400. For example, implant 400 may comprise of material(s) (e.g.,Nitinol and/or any other material mentioned in this disclosure) that hasan equilibrium size and/or shape that is smaller than the expanded statein which it is embedded into the tissue surrounding and/or including themitral valve. As implant 400 returns to its equilibrium size and/orshape, a radially inward restoring force reduces both implant 400 andmitral valve 104, which in turn can reduce mitral regurgitation. In someembodiments, the mitral valve size and/or shape change can occur at thelevel of the proximal or distal end of the implant. In contrast toconventional annuloplasty rings which are implanted on an externalcardiac surface, some embodiments as disclosed herein can operablyattach to tissue on an internal (e.g., luminal surface) in the vicinityof the valve annulus.

As another example, the material of implant 400 may also be configuredto react at body temperature to change its size and/or shape. Thethermal expansion and retraction of the material may be used to applythe aforementioned passive forces. When the material (e.g., Nitinol orany other material mentioned in this disclosure) is heated, it expands,and when it is cooled, it retracts. In some embodiments, implant 400, orportions of implant 400, may be cooler than body temperature whenimplanted, and expand to a larger shape when it is warmed by body heat.At body temperature, implant 400 may then be the desired size and/orshape to attach to the tissue surrounding and/or including the mitralvalve. Implant 400 may then be reduced and/or adjusted as desired bysystems and methods described in this disclosure.

In the alternative, implant 400, or portions of implant 400, may be at atemperature warmer than body temperature when it is attached to thetissue surrounding and/or including the mitral valve. As implant 400, orportions of implant 400, cools to body temperature, the restoring forcesmay create an inward radial force that reduces both the size of implant400 and mitral valve 104, which in turn can reduce mitral regurgitation.

In some cases, implant 400 is kept at a desired temperature (e.g.,warmer or cooler than body temperature) before it is attached todelivery catheter 301. In this way, it may be warmer or cooler as it isdelivered.

In some embodiments, delivery catheter 301 (FIG. 3) may also provide amicroenvironment that helps hold the temperature of implant 400 beforeit is delivered to left atrium 102. In this way, it may allow implant400 to be delivered at a temperature warmer or cooler than bodytemperature. For example, delivery catheter 301 may contain a heatingcoil, cooling elements, chemical heating/cooling, insulation, and/or anythermal control known in the art. In some embodiments, the implant cancomprise magnetically controlled shape memory material (MSMs), includingFe—C, Fe—Pd, Fe—Mn—Si, Co—Mn, Fe—Co—Ni—Ti, Ni2MnGa, Co—Ni—Al, Ni—Mn—Ga,and the like. MSMs exhibit a paramagnetic/ferromagnetic transitionbesides a thermoelastic martensitic transformation. In some embodiments,the implant may be comprised of shape memory polymers (SMPs). Such SMPsmay hold one shape in memory or may hold more than one shape in memory.SMPs which hold one shape in memory are generally characterized as phasesegregated linear block co-polymers having a hard segment and a softsegment. The hard segment is typically crystalline, with a definedmelting point, and the soft segment is typically amorphous, with adefined glass transition temperature. Sometimes, however, the hardsegment is amorphous and the soft segment is crystalline. In any case,the melting point or glass transition temperature of the soft segment issubstantially less than the melting point or glass transitiontemperature of the hard segment. Changes in temperature cause the SMP torevert between the original shape and the memory shape. Examples ofpolymers used to prepare hard and soft segments of SMPs include variouspolyethers, polyacrylates, polyamides, polysiloxanes, polyurethanes,polyether amides, polyurethane/ureas, polyether esters, andurethane/butadiene copolymers.

FIGS. 6A-L illustrate example structural details of various embodimentsof the implant illustrated in FIGS. 5A-B. One or more of the structuraldetails and variations illustrated may be used in different embodimentsof the implant, and/or used in combination in a single embodiment. Aperson having ordinary skill in the art should also appreciate that anynumber of the adjustable restraints described may be used on implantembodiments to adjust the size and/or shape. The assortment of sizesand/or shapes presents a range (e.g., a working range) of configurationsof the implant embodiments.

FIG. 6A is a close-up view of a portion of an implant having anut-and-thread mechanism for size and/or shape adjustment. In thisembodiment, implant 600 comprises struts, such as strut 608. Strut 608itself comprises of threaded crown 601 at its apex, and arms 606 and607. Adjacently connected to arms 607 and 606 are anchors 604 and 605,respectively, such as at the base (e.g., the distal end) of the implant.Threaded crown 601 is encircled by nut 602, which can be used forcustomization of the size and/or shape of implant 600. For example, thepositioning of nut 602 along threaded crown 601 may be used to adjustthe relative positioning of anchors 604 and 605. When nut 602 ispositioned closer to anchors 604 and 605 along strut 608, arms 606 and607 may come closer together, which leads to anchors 604 and 605 comingcloser together. Nut 602 may be positioned any number of ways, includingby rotation, sliding, pushing, pulling, and/or any means of mechanicallydriving the nut. Other nuts like nut 602 may encircle the other threadedcrowns of struts of implant 600. In this way, these nuts mayindependently position other anchors. In some cases, such positioningoccurs after the anchors are embedded in the tissue surrounding and/orincluding a mitral valve. Through the manipulation of these nuts andstruts, and consequently the anchors connected to those struts, implant600 may be manipulated and/or adjusted as desired to shape mitral valve104 as desired. It should be appreciated by one of ordinary skill in theart that the independent adjustments of these nuts permit implant 600 tobe sized and/or shaped in many different ways. Such ability to shapeimplant 600 may be clinically desirable in patients with mitralregurgitation needing nonsymmetrical annular adjustment. It will not,however, prohibit symmetrical adjustment if desired. Rather, independentadjustments allow a physician or operator to adjust implant 600 to bestsuit the patient's regurgitant flow reduction. In some embodiments, thethreads and/or nuts can be configured to extend a length axially alongone, two, or more of the struts, such as at least about, about, or nomore than about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of theamplitude of the struts (e.g., the length of the device along itslongitudinal axis).

Nut 602, or other nuts, may be circular, non-circular, an oval,amorphous, and/or any shape and/or size to conform to the shape of thestruts. It may be constructed from material(s) including stainlesssteel, Nickel-Titanium, Cobalt-Chromium, Pyrolytic Carbon, Nitinol,polymer materials (e.g., PEEK), and/or other suitable implant materials.

Implant 600 may also have a plurality of receiver holes (e.g.,apertures), such as receiver hole 603, which may also be used tomanipulate implant 600. Receiver holes may be in any number oforientations, including vertically positioned as in FIG. 6A, horizontal,angled, etc. with respect to the long axis of the implant. They may belocated anywhere along the struts, anchors, and/or implant as desired,aligned horizontally in a ring formation, staggered and axially offset,and the like.

FIG. 6B is an above (top)-view of FIG. 6A and illustrates an example wayof adjusting the shape of an embodiment of implant 600 through therotation nut 602. Nut 602 is positioned on threaded crown 601 of strut608. The threads may be configured such that the rotation of nut 602repositions nut 602 on threaded crown 601, thus adjusting the positionof arms 606 and 607, and consequently anchors 604 and 605 (FIG. 6A). Forexample, the threads of threaded crown 601 may be angled and/orotherwise configured to resemble the threads of a screw. The rotation ofnut 602 could be driven through by the external handle of the deliverycatheter and transmitted through a shaft, rod, and/or tube that connectsto nut 602. Again, other nuts may be used to move other anchors, such asanchor 610.

FIG. 6C illustrates a close-up of an example mechanism for connectingand/or separating connection arms from implants. In this embodiment, animplant (e.g., implant 400) has horizontal receiver holes (e.g.,receiver holes 626 and 625) on the interior of the implant. A pluralityof connection arms may be connected to the receiver holes of the implantduring delivery. These connection arms may reversibly or detachablyconnect the implant to the delivery catheter, and may be used toinitially expand the implant to the second diameter previouslydescribed.

It may be desirable to disconnect the connection arms from the implantat some time. For example, such a disconnection may be desirable afterthe implant has been positioned and the anchors of the implant have beenembedded in the tissue surrounding and/or including a mitral valve, andthe implant has been adjusted. Disconnection at this time would allowthe connection arms and delivery catheter to be removed from the body,leaving only the implant. The separation of the connection arms from theimplant may be performed independently for each receiver hole, orperformed on all receiver holes of the implant simultaneously.

The connection arms may comprise a plurality of tubular members withwires. The tubular members and wires may interact with the receiverholes of the implant while the implant is connected to the connectionarms. For example, tubular member 624 is positioned around receiver hole626 such that wire 627 passes through tubular member 624 and receiverhole 626. Wire 627 may be held in place by a clip, hook, snag, loop,knot, magnet, adhesive, and/or any other mechanism(s) known in the artfor holding a wire in place. In such a position, connection arm 628 isconnected to the implant. Wire 627 can also be cut, electrolyticallydetached, or otherwise detached.

Connection arm 629 is disconnected. Tubular member 622 has been removedso that wire 620 no longer passes through receiver hole 625.Accordingly, tubular hole 623 of tubular member 624 is no longer held inposition around receiver hole 625.

FIG. 6D illustrates an implant embodiment that may be adjusted in sizeand/or shape using a screw-and-clip mechanism. Clip 634 is placed over astrut having arms 636 and 637. The positioning of clip 634 along arms636 and 637 may be adjusted by screw 630, which passes through boss 635(e.g., a screw retainer) and clip 634. Clip 634 is threaded such thatthe rotation of screw 630 moves clip 634 up and down. For example, clip634 may have threads that run in the opposite direction as the threadsof screw 630.

As clip 634 moves down arms 636 and 637, arms 636 and 637 move closertogether, which causes anchors 632 and 633 to gather closer to oneanother. In this way, clip 634 may be used to adjust the size and/orshape of an implant. A person having ordinary skill in the art shouldrecognize that an implant may have a plurality of screw-and-clipmechanisms, such as the one just described, connected to a plurality ofstruts. By positioning the clips, independently or simultaneously, thesize and/or shape of the implant may be adjusted as desired.

The screw-and-clip mechanism may be attached to the outer diameter orthe inner diameter of the implant, and could use a single or a pluralityof screws and clips, depending upon the implant crown quantity and/or asdesired. The threaded members of the screws and clips may measure from,in some embodiments, about 0.4 millimeters in diameter to about 1.5millimeters and be constructed from stainless steel, Nickel-Titanium,Cobalt-Chromium, Pyrolytic Carbon, Nitinol, polymer materials (e.g.,PEEK), and/or other suitable implant materials. In some cases, a #2-56thread size may be used.

FIG. 6E illustrates a cable mechanism that may be used to adjust thesize and/or shape of an implant embodiment. In some embodiments, cable638 encircles implant 642, e.g., in a direction transverse or oblique tothe longitudinal axis of the implant and applies a radially restrictiveforce on implant 642, which may be used to control the size and/or shapeof implant 642. Cable 638 may pass through a plurality of the receiverholes of implant 642 (e.g., receiver hole 603). Cable 638 may be athread, suture, cable, string, wire, ribbon, and/or any sort ofstructure that could pass through the receiver holes (e.g., receiverhole 603) of implant 642. Cable 638 may be tied off at knot 639. In somecases, knot 639 may be a moveable knot (e.g., a slip knot) that allowsthe length of cable 638 to be adjusted. For example, force may beapplied to knot 639 to pull or push it (e.g., medially or laterally)such that cable 638 shortens or lengthens. Force may also be applied toone or more points of cable 638, including the ends of cable 638, inorder to pull portions of cable 638, thereby shortening or lengtheningcable 638. The force may be applied through mechanical drivers and/oractuators, wherein the force is applied through the delivery catheterfrom the handle of the delivery catheter.

In some embodiments, cable 638 may also be shortened by wrappingportions of the cable around a spool/ream. For example, portions ofcable 638 may initially wrap around the spool/ream during delivery, andthe spool/ream may be rotated in order to cause more/less of cable 638to wrap around it. The rotation may be performed by a rotational driver(e.g., the rotational drivers illustrated in FIGS. 13-15). In this way,cable 638 may be shortened or lengthened.

Again, receiver holes or apertures (e.g., receiver hole 603) may bepositioned in various places on implant 642, angles, and/orconfigurations. The receiver holes may also be placed uniformly ornon-uniformly across implant 642. For example, receiver holes may beadjacent to every anchor of implant 642 or adjacent to fewer than everyanchor of implant 642 in order to achieve the desired shape and/or sizeof implant 642.

FIG. 6F illustrates a top-view and a side-view of an implant embodiment.In this embodiment, implant 643 has horizontal receiver holes on itsinterior. As illustrated, cable 640 passes through all the receiverholes of implant 643. However, cable 640 may also pass through a numberof receiver holes less than all of the receiver holes of implant 643.The shape and/or size of implant 643 may be adjusted by loosening ortightening cable 640 using any system and/or method of loosening and/ortightening cables described in this disclosure. Typically, cable 640remains with implant 643 after implant 643 has been implanted in orderto maintain the shape and/or size of implant 643. However, cable 640 mayalso be removed and/or disconnected from implant 643 as desirable.

FIG. 6G shows a side-view and a top-view of an implant embodiment usinga cable mechanism with a cross-cable oriented in a direction other thanaround an outer diameter or an inner diameter of an implant, such astraversing the outer diameter or inner diameter of an implant. In thisembodiment, cable 650 passes through some, but not all, of the receiverholes of implant 653. Additionally, cross-cable 651 is used to connectsegments of cable 650, and may or may not pass through a receiver hole.Cross-cable 651 may be connected to cable 650 by knots, such as knot652, which may be moveable knots (e.g., a slip knot) that allow thelength of cross-cable 651 to be adjusted. For example, force may beapplied to knot 652 to pull or push it (e.g., medially or laterally)such that cross-cable 651 shortens or lengthens. Force may also beapplied to one or more points of cross-cable 651, including the ends ofcross-cable 651, in order to pull cross-cable 651 laterally, therebyshortening or lengthening cross-cable 651. The force may be appliedthrough mechanical drivers and/or actuators, wherein the force isapplied through the delivery catheter from the handle of the deliverycatheter. Just like cable 640, cross-cable 651 may also be adjusted byusing a spool/ream connected to a rotational driver (e.g., therotational drivers illustrated in FIG. 13-15), wherein the rotation ofthe spool/ream causes more/less of cross-cable 651 to wrap around it.This may change the length of cross-cable 651.

It should be appreciated by one having ordinary skill in the art that acable may pass through different receiver holes in order to adjustimplant 653 as desirable. Having a plurality of receiver holes allowsvariability in the shape and/or size of implant 653 using cables.Cross-cables, such as cross-cable 651, may also allow furthervariability in shape and/or size of implant 653. For example, having across-cable may allow a precise adjustment along a particular plane asthe cross-cable is shortened and/or lengthened. Cross-cables may beplaced anywhere along a cable as desired.

Even more variability in shape and/or size of an implant may be achievedby further variations in cable configurations. For example, a pluralityof independent cables may be used to connect various receiver holes ofan implant. FIG. 6H illustrates an implant embodiment having a pluralityof independent cables. Cables 661, 662, and 663 independently connectvarious receiver holes of implant 664. They may be connected to thereceiver holes by knots, such as knot 660. The shape and/or size ofimplant 664 may be adjusted by loosening or tightening one or more ofcables 661, 662, and 663 using any system or method of loosening and/ortightening cables described in this disclosure. In other embodiments,independent cables may cross each other and/or be configured to connectany receiver hole with another. In some cases, a single receiver holemay be connected to more than one cable. In some embodiments, the cablesdo not completely follow the outer diameter or inner diameter of theimplant.

FIG. 6I illustrates an alternative that may use a similar screw-and-clipmechanism as FIG. 6D. The screw-and-clip mechanism uses screw 670, clip671, and boss 673. The screw may vary in size depending on the size ofthe implant and/or as desired. In some embodiments, locking ring 672 maybe positioned distally to clip 671, where locking ring 672 locks thestrut arms 676 and 677 in position, and consequently locks the positionof anchors 674 and 675. Locking ring 672 may remain on the implant afterscrew 670, boss 673, and/or clip 671 have been removed.

There are a number of ways locking ring 672 may be positioned. In someembodiments, locking ring 672 is initially within clip 671. Locking ring672 may be configured such that it stays in place along arms 676 and 677once it has been advanced. For example, locking ring 672 may havedirectional fasteners, cogs, and/or tangs that only allow it to movedownward (e.g., advance) arms 676 and 677. As screw 670 is turned in onedirection, locking ring 672 advances down arms 676 and 677. Once lockingring 671 is positioned, screw 670 may be turned in the other directionto remove screw 670, clip 671, and/or boss 676, and leave locking ring671.

In other embodiments, clip 671 and/or locking ring 672 may be positionedby a cable (e.g., thread, suture, cable, string, wire, etc.). Forexample, clip 671 and/or locking ring 672 may be connected to a cable.The cable may thread through a single or plurality of holes located onarm 676, and then up through holes located on clip 671 and/or lockingring 672. The cable could then connect back down through another holelocated on arm 677. When pulled, the cable may force clip 671 and/orlocking ring 672 down arms 676 and 677, which in turn positions anchors674 and 675. The cable could subsequently be removed, leaving clip 671and/or locking ring 672 behind holding arms 674 and 675 in position.

FIG. 6J illustrates an implant embodiment having diamond-shaped strutsand sharp, pointed apices. In this embodiment, strut 682 has threadedarms 681 and 686 and anchor 684 at its bottom (base). Nut 680 may beused to position threaded arms 681 and 686 of strut 682, andconsequently position anchor 684. For example, nut 680 may be rotatableabout the threads of threaded arms 681 and 686, which may be configuredsuch that the rotation of nut 680 moves nut 680 axially up or down strut682. As nut 682 moves down strut 682, it may tighten strut 682 and/orbring threaded arms 681 and 686 closer together. As a result, anchor 684moves closer to neighboring anchors, such as anchor 685. Implant 665 mayhave a plurality of struts and/or nuts. The nuts may be rotatedindependently or simultaneously in order to adjust the size of implant665.

FIG. 6K illustrates a variation of FIG. 6J. In this embodiment, implant667 has a plurality of diamond-shaped struts, which may be adjusted byclips that are on the lower parts of the struts. The clips may attach tothe threaded arms of neighboring diamond-shaped struts. For example,strut 697 has threaded arm 696, and strut 692 has threaded arm 695.Threaded arms 695 and 696 are connected to anchors 694 and 698,respectively. When clip 691 is rotated, it may move up or down threadedarms 695 and 696. When clip 691 moves down towards anchors 694 and 698along threaded arms 695 and 696, threaded arms 695 and 696 move closertogether. Accordingly, anchors 694 and 698 move closer together.

It should be noted that implants may have uniform/symmetricalconfigurations or non-uniform/non-symmetrical configurations. Forexample, an implant may have sinusoidal struts all around. In otherembodiments, an implant may have diamond-shaped struts all around. Instill other embodiments, an implant may have both sinusoidal struts anddiamond-shaped struts, such as in an alternating fashion. Each strut ofan implant may use the same mechanism(s) (e.g., one or more of themechanisms and/or adjustable restraints illustrated in FIG. 6A-L) toadjust anchor positions, or any strut may use different mechanism(s)than other struts. In some embodiments, struts could have differentshape patterns, such as a flat or plateaued segment in between ascendingand descending arms.

FIG. 6L illustrates various cable lock systems for cables such as cable638 (FIG. 6E), cable 640 (FIG. 6F), cable 650 and 651 (FIG. 6G), and/orcables 661, 662, and 663 (FIG. 6H). The cable lock systems may be usedto lock the cables to a certain length, change the length of the cables(e.g., loosen or tighten, and/or lengthen or shorten), and/or connectcables to each other or to an implant. For example, cable 695 may have aball-and-cone clasping mechanism. By way of illustration, cable 695might have end 688 that connects to clasp cone 696. The balls of cable695 may uni-directionally pass through cone 696 by applying sufficientforce. For example, ball 697 of cable 695 may be pulled through thelarger end of clasp cone 696 through the smaller end by applyingsufficient force. The amount of force required may be changed by theselection of clasp cone 696, which may offer more or less resistance tothe passing of ball 697 as desired. As balls are pulled through claspcone 696, the length of cable 695 shortens. The shape of clasp cone 697prevents balls from being pulled through the smaller end of clasp cone696 back through the larger end, thereby preventing cable 695 from beinglengthened after it has been shortened. When cable 695 is used with animplant, cable 695 may be used to restrict the implant and hold theimplant to a shape and/or size. The ball elements need not necessarilybe spherical as shown, and can take the form of beads, cubical,rectangular, pyramidal, or other elements having at least one dimensiongreater than that of the cable.

Alternatively, a structure similar to a cable-tie may be used, such as aone-way ratchet or zip tie for example. For example, cable 699 may havea plurality of ridges. Clasp 698 may be attached to end 689 of cable699. Clasp 698 may be configured to interact with the ridges of cable699 such that cable 699 can pass through clasp 698 when cable 699 ispulled with sufficient force in a certain direction. This mechanism mayutilize a directional clip inside clasp 698, where the clip slides intothe ridges of cable 699. When ridges are pulled through clasp 698, cable699 shortens. Because clasp 698 prevents cable 699 from being pulled inthe opposite direction, clasp 698 prevents cable 699 from beinglengthened. As a result, cable 699 may be used to restrict an implant.

FIG. 7 illustrates an example tilt adjuster that may be used with thedelivery catheter illustrated in FIG. 5A. Delivery catheter 301 may havetilt adjuster 702. Tilt adjuster 702 may connect to connector arms 401,which run through at least part of the length of delivery catheter 301and connect to implant 400. The sheath of delivery catheter 301 has beenwithdrawn to expose connector arms 401 and implant 400. By actuatingtilt adjuster 702, connector arms 401 may be moved in order to tiltimplant 400 as desired. In some cases, the movement of tilt adjuster 702pulls and pushes the various wires in connector arms 401, which in turncauses implant 400 to tilt and/or move out of plane. Such tilting may bedesirable to navigate implant 400 into position in the heart. Typically,tilting can vary from minus 30 degrees to plus 30 degrees at anyselected angle. Guidewire 306 may run through delivery catheter 301. Insome cases, guidewire 306 may extend through tip 307, as alsoillustrated in FIG. 5A.

FIG. 8 illustrates an example tapered implant with a diamond pattern.Implant 800 has a plurality of diamond cuts, such as diamond cut 801. Italso has a conical shape, where the top (distal to the anchors) isnarrower than the bottom (proximal to the anchors). Implant 800 also hasa plurality of receiver holes, such as receiver holes 802 and 803,located at numerous spaced axially and/or radially apart places.Receiver holes may be located anywhere as desired on implant 800. Forexample, a receiver hole may be located at a point on implant 800 inorder to allow adjustment of sections of implant 800 adjacent to thatpoint using cables and/or connection arms as previously described inthis disclosure. By way of illustration, receiver hole 803 may bepositioned near anchor 804 in order to allow a cable to connect toreceiver hole 803 and adjust the position of anchor 804. Receiver hole803 may interact with cables in order to adjust the size and/or shape ofimplant 800 in any way(s) described in this disclosure.

In some embodiments, implant 800 may be initially configured such thatthe upper-end is smaller or larger in diameter than the lower-end, aspictured in FIG. 8, such as about or at least about 5%, 10%, 15%, 20%,25%, 30%, 40%, 50%, or more greater than the other respective end. Thelower-end may have anchors that are positioned to allow for an angularimplantation of the anchors into the tissue surrounding and/or includingthe mitral valve. Once the anchors have been fixed to the tissue, thetapered implant could switch orientation so that the lower-end becomessmaller in size and the upper-end becomes larger. Such switching couldbe initiated by the downward force of embedding the anchors into thetissue, where the struts of the implant are configured to fliporientation due to the downward force. In some cases, the implant mayhave an equilibrium shape where the upper-end is larger than thelower-end. The downward force of embedding the implant while it is notin its equilibrium shape (e.g., while the lower-end is larger than theupper-end) may cause the implant to flip back to its equilibrium shape,thereby causing the lower-end to contract—which would cause the tissueconnected to the lower-end to contract as well.

In other embodiments, the orientation switching may also occur due toradial forces, supplied from the handle of the delivery catheter,applied to the upper-end and/or lower-end of implant 800. For example,connection arms connected to receiver holes of the upper-end of implant800 may force the upper-end to expand. In some cases, a balloon may alsobe used to push the upper-end wider. In some cases, cables mechanisms,as in any cable mechanism described in this disclosure, may be used topull the upper-end diameter larger and/or pull the lower-end diametersmaller. Tapered implants such as implant 800 may be diamond-patternedand/or sinusoidal.

FIG. 9 illustrates an example retractable anchor mechanism that may beused in some implants. Structure 900 may comprise retractable anchor902, which may be exposed and/or manipulated to interact with hearttissue. In some embodiments, anchor 902 may be lowered (e.g., moveddistally) to be exposed, such as along a track or guide rail. In theexposed state, it may be embedded into tissue surrounding and/orincluding a mitral valve. In contrast, when anchor 902 is retracted(e.g., raised up, e.g., proximally), anchor 902 may not be exposed. Theretracted state may be desirable to prevent interaction between anchorsand tissue as the implant is positioned in the heart, and before theimplant is embedded into the tissue surrounding and/or including amitral valve. States between retracted and exposed may be used tocontrol the depth anchor 902 embeds in tissue. Anchor 902 may bepositioned using slide 904, which may be coupled to spokes 906 of anchor902. Slide 904 may use lockable rails and/or clips that interact withspokes 906 to lock anchor 902 in place.

FIG. 10 illustrates an example anchor being removed from an anchor coveror sheath. For example, anchor 1002 may be covered by anchor cover 1001to prevent interaction of anchor 1002 and tissue until anchor 1002 isexposed. Control rods, such as tubular member 1003, which may bestructured like tubular member 624 (FIG. 6C) and/or part of a connectionarm, may be connected to anchor 1002 and pull it from anchor cover 1001.In this way, anchor 1002 may be exposed in order to embed anchor 1002into the tissue surrounding and/or including a mitral valve, and/or whendesired.

In some embodiments, the actuation or exposure of anchor 1002 may besimultaneous with device expansion or secondarily initiated through thedelivery catheter using a proximal control such as a push or pull memberto advance anchor 1002 out of anchor cover 1001 using tubular member1003. An alternative may be a rotational or screw mechanism to advanceanchor 1002 distally out of anchor cover 1001.

FIG. 11 illustrates the expanded shape of an example implant from a topand side view. Implant 1100 may be an oval or substantially shape wherethe long axis measures about 30 to 40 millimeters and the short axismeasures about 15 to 25 millimeters. Such a shape may be desirable insome circumstances in order to better match a desired mitral valve shapeof a patient. In some embodiments, implant 1100 may be adjusted usingmechanisms described in this disclosure in order to better match thedesired shape of the mitral valve of a patient.

FIG. 12 illustrates an example implant where the amplitude isnonsymmetrical about the implant's diameter. Implant 1200 has a higherphase along the ends of its minor axis and a lower phase along the endsof its major axis. For example, anchor 1202 is positioned with anamplitude change 1201 higher than anchor 1203. The clinical benefit ofhaving such amplitude variation in the implant is that it allows theimplant to be rotated into position where the lower phase, or longerstruts, would reach out farther to the commissures of a mitral valve.This may be desirable in some cases because the mitral valve (and/orannulus) can be non-planar and more saddle-shaped, and also variespatient-to-patient and/or with the progression of a disease state.

In some embodiments, implant 1200 could feature a three-dimensionalsaddle shape similar to a GEOFORM ring from Edwards Lifesciences(Irvine, Calif.), which may better match the mitral valve'sthree-dimensional anatomy in some cases. This three-dimensional saddleshape may reflect a mitral valve's reduced anterior-posterior distanceand an elevated P2 segment. In some cases, the saddle shape has a top(distal to the anchors) linear segment, with a bottom (proximal to theanchors) bi-curved segment. In some embodiments, a plurality of anchorsat opposing sides of the implant have a lower phase than the otheranchors.

In some embodiments, the wall thickness of implant 1200 could measureabout 0.010 to about 0.030 inches and could vary from top to bottom oron individual radial segments to change the stiffness of implant 1200 atlocations about implant 1200. Prior to implantation, diameter grindingand/or lateral grinding of implant 1200 could be used to selectivelyremove material around implant 1200 as needed. The grinders could be setwith rotary fixtures to adjust implant 1200 accordingly for selectiveremoval of material.

Adjusting the size and/or shape of an implant described in thisdisclosure may require mechanical drivers and/or actuators to adjust theposition of adjustable restraints (e.g., screws, nuts, and/or cables)and/or other structures of the implant (see, e.g., FIGS. 6A-L). Suchmechanical drivers and/or actuators may include a variety of mechanismsthat may rotate, slide, push, pull, and/or actuate structures of theimplant. In some embodiments, rotational drivers may be connected to theimplant through the handle of the delivery catheter.

FIG. 13 illustrates an example of a hook-and-wire rotational driver thatcan be used to manipulate an implant. Member 1300 may connect to ascrew, nut, and/or other rotatable structure of an implant (see, e.g.,FIGS. 6A-L). Member 1300 may comprise tubular cover 1301 and loop 1304.Rotational driver 1305 may comprise hook 1303 and stopper 1302.Rotational driver 1305 may be connected to an external handle of thedelivery catheter used to position the implant, where force is suppliedto rotational driver 1305 at the handle. Rotational force may be appliedthrough rotational driver 1305 to rotate member 1300.

During delivery of the implant, rotational driver 1305 may be connectedto member 1300. In the connected position, hook 1303 is positioned inloop 1304. Rotational driver 1305 and member 1300 may be pushed togethersuch that hook 1303 and loop 1304 are positioned inside tubular cover1301. Stopper 1302 may be positioned in a ridge in tubular cover 1301 tofurther stabilize the connection between rotational driver 1305 andmember 1300, and to facilitate the transfer of rotational force fromrotational driver 1305 to member 1300. This transfer of rotational forcemay turn a nut (e.g., nut 602 of FIG. 6A), a screw (e.g., screw 630 ofFIG. 6D), a spool/ream (e.g., to control the length of cable 640 of FIG.6F), rotate the implant, and/or rotate any part/component of theimplant. After the implant is positioned and/or sized/shaped as desired,rotational driver 1305 and member 1300 may be disengaged by pulling themapart and unhooking hook 1303 from loop 1304. Rotational driver 1305 andmember 1300 may also be re-engaged by placing hook 1303 in loop 1304,and pushing rotational driver 1305 into tubular cover 1301.

FIG. 14 illustrates an example two-arm rotational driver that is similarto the rotational driver of FIG. 13. Member 1400 may be fitted with hook1406. Rotational driver 1405 may be fitted with hook 1407 that isconfigured to connect with hook 1406.

During delivery of the implant, rotational driver 1405 may be connectedto member 1400. In the connected position, hook 1407 is clasped to hook1406. Rotational driver 1405 and member 1400 may be pushed together suchthat hook 1407 and 1406 are positioned inside tubular cover 1401.Stopper 1402 may be positioned in a ridge in tubular cover 1401 tofurther stabilize the connection between rotational driver 1405 andmember 1400, and facilitate the transfer of rotational force fromrotational driver 1405 to member 1400. This transfer of rotational forcemay turn a nut (e.g., nut 602 of FIG. 6A), a screw (e.g., screw 630 ofFIG. 6D), a spool/ream (e.g., to control the length of cable 640 of FIG.6F), rotate the implant, and/or rotate any part/component of theimplant. After the implant is positioned and/or sized/shaped as desired,rotational driver 1405 and member 1400 may be disengaged by pulling themapart and unhooking hooks 1407 and 1406 from each other. Rotationaldriver 1405 and member 1400 may also be re-engaged by clasping hooks1407 and 1406 together, and pushing rotational driver 1405 into tubularcover 1401.

FIG. 15 illustrates an example hex rotational driver that can be used tomanipulate an implant. Rotational driver 1510 has clasp 1513 andscrewdriver head 1514. During delivery, screwdriver head 1514 and screwhead 1512 may be engaged with clasp 1513 closed around them. Whileengaged, rotational force may be transferred from rotational driver 1510to screw 1511. The rotational force may be supplied to screw 1511 byrotating screw driver head 1514 and/or rotating rotational driver 1510.The rotation of screw driver head 1514 and/or rotational driver 1510 maybe controlled and/or supplied from the external handle of the deliverycatheter.

Screw 1511 may be, for example, any screw described in this disclosure(e.g., screw 630 of FIG. 6D). Screw 1511 may also be coupled to anyrotatable part/component of an implant in order to transfer rotationalforce. For example, screw 1511 may be coupled to adjustable restrains,such as a nut (e.g., nut 602 of FIG. 6A), a spool/ream (e.g., to controlthe length of cable 640 of FIG. 6F), an implant (e.g., to rotate theimplant), and/or rotate any part/component of the implant.

In some embodiments, rotational driver 1510 and screw 1511 may bedisengaged by opening clasp 1513 and pulling rotational driver 1510 awayfrom screw 1511. The arms of clasp 1513 may be opened by a desiredcontrol such as a switch (e.g., a switch on the handle of the deliverycatheter), pulley system, clasp system, and/or any other method known inthe art for mechanically driving the opening of the arms of a clasp.Rotational driver 1510 and screw 1511 may be re-engaged by opening clasp1513 and pushing rotational driver 1510 into screw 1511 again.

FIGS. 16A-B illustrate a side-view and top-view of a rotational driverthat can be used to rotate a nut over a strut in an appropriatedirection. FIG. 16A illustrates a side-view of rotational driver 1608engaged and disengaged from strut 1605. FIG. 16B illustrates a top-viewof rotational driver 1608 disengaged from strut 1605. Strut 1605 hasthreads cut along it. Strut 1605 may be, for example, any of the strutsdescribed in this disclosure (see, e.g., FIGS. 6A-L). The threads areconfigured such that the rotation of nut 1601 moves nut 1601 along(e.g., axially) strut 1605. Rotational driver 1608 comprises cog 1607that is configured to engage nut 1601. Small bent wire 1602 or a similarmechanism may be used as a counter force to keep nut 1601 and rotationaldriver 1608 engaged by hooking into space 1609 of strut 1605.

During delivery, small bent wire 1602 is hooked into space 1609 and nut1601 and rotational driver 1608 are engaged. Rotational driver 1608 andnut 1601 are pushed together so that they are locked together, and space1609 and cog 1607 are positioned in tubular cover 1610. In this state,rotational force may be applied through rotational driver 1608 to rotatenut 1601, thereby moving it along (e.g., axially) strut 1605. Therotation of rotational driver 1608 may be controlled and/or suppliedfrom the external handle of the delivery catheter. Nut 1601 and cog 1607may be disengaged by pulling them apart and disconnecting small bentwire 1602 from space 1609. Rotational driver 1608 and strut 1605 mayalso be re-engaged by hooking small bent wire 1602 and space 1609together, and pushing rotational driver 1608 and strut 1605 together.

FIGS. 17A-B illustrate an example push-slider mechanism that may be usedto manipulate an implant. FIG. 17A illustrates a side-view of push tube1702 engaged and disengaged from strut 1700 respectively. FIG. 17Billustrates a top-view of push tube 1702 disengaged from strut 1700.

Push tube 1702 may be used to push clip 1701 or other adjustablerestraints down strut 1700. The movement (e.g., axial movement) of pushclip 1701 may draw the arms 1705 and 1707 of strut 1700 closer to oneanother, which in turn may pull the anchors attached to arms 1705 and1707 of strut 1700 together. Where the anchors are attached to thetissue surrounding and/or including a mitral valve, the tissue issimilarly pulled together. Push clip 1701 may have an outer diameter andan inner diameter with a single or a plurality of fingers protrudinginward creating a cog that interacts with the ridges of arms 1705 and1707 to limit motion in one direction. The shape of push clip 1701 maybe non-circular and/or an oval to better conform to the shape of strut1700. Push clip 1701 may be constructed from stainless steel,Nickel-Titanium, Cobalt-Chromium, Pyrolytic Carbon, Nitinol, polymermaterials (e.g., PEEK), and/or other suitable implant materials. Acounter force may be supplied from wire 1703, which hooks into space1708 of strut 1700 and holds push tube 1702 to strut 1700, therebyconnecting them. During delivery, wire 1703 may be placed in space 1708,and push tube 1702 and clip 1701 may be pushed together. Push tube 1702and clip 1701 may be disengaged by unhooking wire 1703 from space 1708and pulling push tube 1702 away from clip 1701 and strut 1700. They maybe re-engaged by hooking wire 1703 into space 1708 and pushing push tube1702 into clip 1701.

FIG. 18A illustrates an example delivery system for an implant havingforward (distal) facing anchors for entry from the left atrium, or forentry from a femoral vein and a transseptal puncture. The force forengaging implant 1811 into the heart tissue would be, in some cases, aforward or pushing mechanism to engage the anchors of implant 1811.Included in the delivery system is guidewire 1810. Sheath 1812 may coverimplant 1811 before it is expanded for delivery and positioning. Thedistal end of sheath 1812 may include a pre-shaped curve to match theanatomical needs of the patient. The distal end may also have an activeability to steer, curve, and/or rotate for delivery and/or positioning.Handle 1813 may allow for accurate positioning of implant 1811 andtransmission of forces to implant 1811. Additionally, handle 1813 mayallow for adjustments of implant 1811 through driver mechanisms,including any driver mechanism described in this disclosure. Forexample, in some embodiments, handle 1813 may have rotational drivers1814, which may be any rotational driver described in this disclosure.Implant 1811 may also be, for example, any implant described in thisdisclosure, including ones that have sinusoidal, diamond-patterned,and/or tapered struts.

FIG. 18B illustrates an example delivery system for an implant havingproximal facing anchors for entry from a left ventricle (e.g., atransapical entry). Implant 1801 may pass through a left ventricle intothe left atrium, and be exposed by a removal of sheath 1802 at thedistal end. The removal of sheath 1802 may allow implant 1801 to expandor to be forcefully expanded by connection arms or other expansionmechanisms such as a balloon and/or any mechanism described in thisdisclosure for example. For example, implant 1801 may be connected toconnection arms that shape implant 1801 to a diameter and/or shape tomatch the patient's mitral valve anatomy. As another example, aplurality of nuts (e.g., nut 602 (FIG. 6A), nut 680 (FIG. 6J), nut 691(FIG. 6K)), clips (e.g., clip 634 (FIG. 6D) and clip 671 (FIG. 6I)),rings (e.g., locking ring 672 (FIG. 6I)), and/or cables (e.g., cable 640(FIG. 6F)) may be positioned as to compress the size and/or shape ofimplant 1801, or any implant of this disclosure, while it is beingdelivered. The nuts, clips, and/or cables may be repositioned afterimplant 1801 has been delivered in order to expand implant 1801.

Handle 1803 may allow for adjustments of implant 1801 through drivermechanisms, including any driver mechanism described in this disclosure.Because of the proximal facing anchors of implant 1801, a screw-and-clipmechanism, similar to the mechanisms illustrated in FIG. 6D and/or FIG.6I, may be suited to gather the struts of implant 1801 together. Thescrew-and-clip mechanism may be actuated by rotational drivers 1804located at the proximal end of handle 1803. Rotational drivers 1804 mayalso implement any of the other actuating mechanisms described in thisdisclosure.

FIG. 19 illustrates a close-up of an example implant with proximalfacing anchors with screw-and-clip mechanisms to adjust the shape and/orsize of the implant. For example, implant 1906 has strut 1903 that isconnected to anchors 1904 and 1907. Strut 1903 has clip 1902, which isconfigured to gather the arms of strut 1903 closer together as clip 1902advances along strut 1903. As the arms of strut 1903 gather together, sodo anchors 1904 and 1907, and any tissue to which anchors 1904 and 1907may be embedded. Attached to strut 1903 is threaded boss 1901 (which maybe a screw retainer) to drive screw 1900 and clip 1902 up and down strut1903. For example, loosening screw 1900 relative to boss 1901 moves clip1902 downward, pulling the arms of strut 1903 together. Other struts ofimplant 1906 may have similar configurations and may be adjusted incoordination or independently.

FIG. 20 illustrates a close-up of the implant of FIG. 19 where thescrew-and-clip mechanisms reduce the diameter of the implant. Theactuation of the clips (e.g., clip 1902) may occur after anchors (e.g.,anchors 1904 and 1907) are engaged into the tissue surrounding and/orincluding a mitral valve. The clips may also be in a downward positionwhile implant 1906 is being delivered to a left atrium. The actuation ofthe clips may be driven by rotational drivers 1905, which may becontrolled outside the body at the proximal end of the delivery system(see, e.g., rotational drivers 1814 (FIG. 18A) and rotational drivers1804 (FIG. 18B)). Rotational drivers 1905 may connect to the screws(e.g., screw 1900) of implant 1906. In some embodiments, rotationaldrivers 1905 may also serve as connection arms that connect implant 1906to a delivery catheter. The adjustment of the rotational drivers 1905could also be reversed if the regurgitant flow of the mitral valve wasaltered negatively or added to the regurgitant flow volume.

FIG. 21 illustrates a close-up of an example implant with distal facinganchors and screw-and-clip mechanisms to adjust the shape and/or size ofthe implant. Implant 2107 has a plurality of distal facing anchors, suchas anchors 2105. The size and/or shape of implant 2107 may be adjustedin a similar way as implant 1906 illustrated in FIGS. 19 and 20 and usea screw-and-clip mechanism similar to those depicted in FIG. 6D and FIG.6I. For example, rotational drivers 2101 connect to and deliverrotational force to the screws of implant 2107, including screw 2103. Inthis way, clip 2106 may be moved along strut 2104 by a rotational forcefrom rotational drivers 2101. The rotational force may be translated toscrew 2103 through boss 2102 (which may be a screw retainer). Similar tothe implant illustrated in FIG. 20, the actuation may be controlledoutside the body at the proximal end of the delivery system (see, e.g.,rotational drivers 1814 (FIG. 18A) and rotational drivers 1804 (FIG.18B)). The movement of the clips may be used to increase or decrease thesize of implant 2107. In some embodiments, rotational drivers 2101 mayalso serve as connection arms that connect implant 2107 to a deliverycatheter.

FIG. 22A illustrates a close-up of an example implant with proximalfacing anchors and connection arms connected to the implant. Implant2202 has similar screw-and-clip mechanisms as FIG. 19. Additionally,connection arms 2200 are connected to implant 2202 to allow for deviceexpansion during delivery. Connection arms 2200 can be pre-shaped tomake implant 2202 into a circular, oval, and/or elliptical shape tomatch the patient's mitral valve anatomy. Connection arms 2200 aredesigned to connect a handle and delivery system to implant 2202 forprecise implant placement.

Connection arms 2200 may connect to implant 2202 by rotational screwsthat engage implant 2202. Connection arms 2200 may also connect toimplant 2202 by tubular elements with wires passing through them. Forexample, tubular element 2203 has connection wire 2201 passing throughit. Wire 2201 may then additionally pass through a receiver hole inimplant 2202 to secure tubular element 2203 and the receiver holetogether (see, e.g., FIG. 6C).

Once wire 2201 is retracted, tubular element 2203 becomes free todisengage from implant 2202. Similarly, some or all of the tubularmembers of connection arms 2200 may be disengaged from implant 2202.Tubular element 2203 can be constructed from materials includingstainless steel, Nickel-Titanium, Cobalt-Chromium, Pyrolytic Carbon,Nitinol, polymer materials (e.g., PEEK), and/or other suitable implantmaterials. In some cases, where connection arms 2200 are pre-shaped,they provide a passive force expanding implant 2202 outward andcontrolling the shape of implant 2202.

FIG. 22B illustrates an example implant with proximal facing anchors andconnection arms attaching the implant to a delivery system. Tip 2202 ofdelivery system 2206 is shown in the left image in a distal position. Ifpulled proximally (as in the right figure), tip 2202 may push connectionarms 2205 apart from each other as tip 2202 is disposed betweenconnection arms 2205. This action may expand implant 2207 to a largerdiameter and/or shape for embedding into the tissue surrounding and/orincluding a mitral valve. Additionally, it should be appreciated thatthe expanded shape of implant 2207 may reflect the shape of tip 2202.Accordingly, tip 2202 may have a round, oval, elliptical and/oramorphous shape in order to shape connection arms 2205 and implant 2207to better reflect the desired shape of the mitral valve when tip 2202 ispulled proximally. The disengagement of connection arms 2205 and tip2202 from implant 2207 may allow implant 2207 to reduce in diameterthrough passive or active forces, as described in this disclosure.

FIG. 23 illustrates example anchor configurations of various shapes.Anchor 2300 has symmetrical barbs on either side of it. Anchor 2301 isasymmetrical, and has a barb on only one side, but also hasapproximately equal width to anchor 2300. The more prominent extensionof the single barb may increase tissue engagement depth. Because anchor2301 has approximately the same width as anchor 2300, in some cases itmay provide a lower insertion force and have a bias to one side forlateral movement when a plurality of anchors such as anchor 2301 aremoved towards one another.

Additionally, the order in which anchors are embedded and/or thesequencing of the various anchors of an implant may also vary asdesired. For example, formation 2305 has anchors 2307 and 2306 that haveopposing barbs that face each other. The implant may further sequenceits anchors such that each anchor of the implant has an anchor with abarb facing it in a similar formation as formation 2305.

In some embodiments, an implant may also not embed all anchors into thetissue surrounding and/or including a mitral valve simultaneously. Forexample, every other anchor may be embedded first and/or only anchorswith barbs facing in one direction may be embedded first (e.g., onlyanchors having barbs facing the same direction as anchor 2306 may beembedded first). The embedded anchors could first be adjusted by initialadjustments of the implant. The anchors that were not first embeddedcould then be embedded to finish the adjustment of the implant.Synchronizing the embedding of the anchors in this way may providebetter securement of the implant to the tissue surrounding and/orincluding a mitral valve. The anchors may also later by cinched to pushfacing anchors (e.g., anchors 2306 and 2307) closer together for abetter hold.

Similar synchronizing may be applied to implants with other anchorformations (e.g., implant 2302) and/or implants having any size and/orshape including those as described in this disclosure. The degree ofsynchronizing and/or sequencing could be selected and varied dependingupon the operator's intent and the patient's need and/or disease state.

FIG. 24 illustrates an example implant with anchors covered withslideable elements. Independent activation or exposure of the anchors ofan implant may occur by using multiple ribbons configured to push orpull slideable elements (e.g., anchor covers) that cover the anchors.For example, ribbons 2406 may extend from collar 2400 to connect toslideable elements of implant 2405 in order to control the slideableelements. The slideable elements may cover the anchors of the implant.For example, slideable element 2403 covers anchor 2401. Ribbons 2406 mayalso aid in maintaining lateral rigidity and increasing inwardflexibility of implant 2405 in conjunction with connection arms 2407.Delivery catheter 2404 may be used to guide implant 2405 into position.

In some cases, wires may pass through implant 2405 and ribbons 2406 inorder to connect them together. The wires may be withdrawn in order toseparate ribbons 2406 from implant 2405 in manners similar to othersdescribed in this disclosure (see, e.g., FIG. 6C). Ribbons 2406 could beconstructed of material(s) including stainless steel, Nickel-Titanium,Cobalt-Chromium, Pyrolytic Carbon, Nitinol, polymer materials (e.g.,PEEK), and/or other suitable implant materials. Ribbons 2406 may have apre-shaped form or a simple flat shape that can be forced open andclosed radially. FIG. 25 illustrates the example implant from FIG. 24with anchors exposed and ready for implantation.

FIGS. 26A-C illustrate an example anchor that has a helical shape and asharp distal end that can be rotated through an extension of an implantstrut to engage the tissue surrounding and/or including a mitral valve.FIG. 26A illustrates a side-view of example anchor 2602, which has ahelical shape. FIG. 26B illustrates a front-view, and FIG. 26Cillustrates an angled view of the same anchor 2602.

Strut 2600 may have extension 2601, which comprises of holes. The holes(e.g., hole 2603) of extension 2601 may be configured such that anchor2602 may pass through the holes with its helical shape. The helicalshape of anchor 2602 may spiral through the holes, adjustably connectingto the tissue surrounding and/or including a mitral valve. One havingordinary skill the art should appreciate that anchor 2602 may beextended downward or retracted upward by rotating it such that the coilsof anchor 2602 pass through the holes of extension 2601.

Anchor 2602 may be a screw-form constructed of material(s) includingstainless steel, Nickel-Titanium, Cobalt-Chromium, Pyrolytic Carbon,Nitinol, polymer materials (e.g., PEEK), and/or other suitable implantmaterials. The cross-sectional diameter of anchor 2602 may measure insome embodiments between 0.010 and 0.025 inches and be coiled at a pitchof between 20 and 60 coils per inch, measuring about 0.03 to 0.08 inchesin outer diameter. The overall length of anchor 2602 may measure, forexample, about 0.2 to 0.5 inches.

FIG. 27 illustrates an example anchor that has a helical shape that canbe rotated through an implant strut to engage the tissue surroundingand/or including a mitral valve. Anchor 2701 is similarly constructed toanchor 2602 of FIG. 26A-C. Strut 2700 may have holes 2702, which may bepatterned in diagonal and/or oblique positions such that anchor 2701 maypass through them. Again, anchor 2701 may be extended downward orretracted upward by rotating it such that the coils of anchor 2701 passthrough holes 2702.

FIG. 28 illustrates an example implant with anchors that have a helicalshape. Implant 3000 is in a delivery state that is smaller in diameterthan its normal unconstrained state, allowing for its advancement into aleft atrium via a delivery catheter. In some embodiments, implant 3000may be still attached to a delivery catheter and the helical-shapedanchors of implant 3000 may be still in their retracted positions. Forexample, anchor 3003 is helical-shaped and passes through holes 3004,which may be similar to holes 2702 (FIG. 27). As illustrated, anchor3003 is in a retracted position such that it does not extend far beyondholes 3004. Anchor 3003 has cap 3002, which may be connected to arotational driver. The rotational driver may comprise the rotationaldrivers illustrated in FIGS. 13, 14, 15, and/or 16A-B, and/or anyrotational driver described in this disclosure for example. Implant 3000also has nuts, such as nut 3001, which are located on the struts ofimplant 3000 to adjust the size and/or shape of implant 3000. Nut 3001may be similar to nut 602 illustrated in FIGS. 6A-B and may be rotatedby any rotational drivers of this disclosure, including the rotationaldrivers illustrated in FIGS. 13, 14, 15, and/or 16A-B. Upon delivery toa left atrium and/or after implant 3000 has been expanded, anchor 3003may be rotated such that it extends downward to engage the tissuesurrounding and/or including a mitral valve.

FIG. 29 illustrates the example implant of FIG. 28 in a radiallyexpanded state. Implant 3000 has been expanded to engage the tissuesurrounding and/or including a mitral valve. Anchors, such as anchor3003, are still positioned in the retracted position.

FIG. 30 illustrates the example implant of FIG. 29 where the anchorshave been extended. For example, anchor 3003 has been rotated such thatit has extended downward. In this way, it may extend into the tissuesurrounding and/or including a mitral valve. Each anchor may be rotatedindividually or connected to one another for simultaneous extension.

FIG. 31 illustrates the example implant of FIG. 30 where the exampleimplant has been contracted. Nuts, such as nut 3001, have been advancedalong their respective struts in order to reshape implant 3000. Becauseanchors, such as anchor 3003, have been extended to engage the tissuesurrounding and/or including a mitral valve, the reshaping of implant3000 further reshapes that mitral valve.

One having ordinary skill in the art should appreciate that anchorshaving helical shapes may be adapted to any of the implants and/ormechanisms described in this disclosure. It should also be appreciatedthat implant 3000 may be adapted to use any of the mechanisms foradjusting size and/or shape described in this disclosure. For example,implant 3000 may use a plurality of adjustable restraints, includingnuts (e.g., nut 602 (FIG. 6A), nut 680 (FIG. 6J), nut 691 (FIG. 6K)),clips (e.g., clip 634 (FIG. 6D) and clip 671 (FIG. 6I)), rings (e.g.,locking ring 672 (FIG. 6I)), and/or cables (e.g., cable 640 (FIG. 6F)).These adjustable restraints may be used to adjust the size and/or shapeof implant 3000 within a working range. In some embodiments, cables mayalso be adapted to connect to caps, such as cap 2002. In this way, thecables may provide further adjustment of the size and/or shape ofimplant 3000.

In some embodiments, a replacement prosthetic heart valve may beoperatively coupled to any implant described in this disclosure. Thevalve may be positioned within the mitral, aortic, or other valveannulus and disposed axially within the central lumen of the implantbody, and in some cases in a minimally-invasive procedure such as atranscatheter mitral or aortic valve replacement procedure. In someembodiments, the valve may include a stent frame operably attached toprosthetic leaflet(s) configured to coapt the valve. For example, thereplacement prosthetic valve may comprise a nitinol support frame havingdiamond-patterned or other cells, wherein the frame is configured tosupport the leaflets of the mitral valve. In some embodiments, thereplacement prosthetic valve may comprise a bioprosthetic valveleaflets, such as those derived from bovine, equine, or porcine tissue,such as pericardial tissue for example, or any tissue derived from orobtained from an animal. In other embodiments, the valve may be anyvalve replacement known in the art. In some embodiments, the implants asdescribed herein can be utilized as a “docking station” or scaffold totemporarily or permanently be operably connected to, for example, avariety of physiologic sensors measuring pressure, hemoglobin, oxygen,carbon dioxide, and the like across the valve, and other diagnostic andtherapeutic devices, including drug delivery/infusion devices.

The implant may comprise connectors that allow it to connect to thevalve. For example, the implant may comprise hooks, clasps, tangs,clips, fasteners, and/or cogs positioned radially inward in order toclasp, hold, clip, and/or otherwise interact with the replacementprosthetic valve. In some cases, the hooks, claps, tangs, clips,fasteners, and/or cogs may be positioned radially inward at an angle(e.g., +/−0, 10, 20, 30, 40, 50, 60, 70, 80, and/or 90 degrees, and/orany angle between any two of the aforementioned angles). The hooks,clasps, tangs, clips, fasteners, and/or cogs may also be positioneddistally, proximally, and/or at an angle between distally and proximally(e.g., +/−0, 10, 20, 30, 40, 50, 60, 70, 80, and/or 90 degrees, and/orany angle between any two of the aforementioned angles) in order toclasp, hold, clip, and/or otherwise interact with the replacementprosthetic valve. In some embodiments, the implant may also comprisecable(s), wherein the cable(s) are configured to hold the implant andthe replacement prosthetic valve in place. For example, one end of anadjustable cable (e.g., a cable that may be lengthened and/or shortenedusing any mechanism described in this disclosure) may be tied to theimplant (e.g., in a receiver hole and/or strut of the implant) using aknot. The other end of the cable may be tied to the replacementprosthetic valve (e.g., to a diamond-patterned cell and/or receiverhole) using a knot. In other cases, a cable may pass through thereplacement prosthetic valve and the implant, and the ends of the cablemay be tied together to hold the valve and the implant together. Forexample, a cable may pass axially through the frame of adiamond-patterned cell and/or a receiver hole of the replacementprosthetic valve, and pass axially through a strut and/or receiver holeof the implant. The ends of the cable may be tied together to secure theimplant and the replacement prosthetic valve together. In any of theaforementioned ways, the implant may hold the valve in place and secureits placement. As such, the implant may act as a docking station for thereplacement prosthetic valve. In some cases, the replacement prostheticvalve and the implant may behave functionally as a replacementprosthetic valve with anchors for securement.

The valve may be delivered to the mitral valve before, after, or at thesame time as any implant described in this disclosure. For example, thereplacement prosthetic valve may be delivered independently of theimplant through one of several methods, including transfemoral,transapical, subclavian, and direct aortic implantation. The replacementprosthetic valve may then be placed within the implant, or the implantmay be place around the replacement prosthetic valve. For example, insome cases where the replacement prosthetic valve is positioned in thevalve region before the implant, the implant may expand so that thereplacement prosthetic valve may be medially positioned within theimplant's frame. Once the replacement prosthetic valve is mediallypositioned within the frame of the implant, the implant may contractaround the replacement prosthetic valve, causing the hooks, clasps,tangs, clips, fasteners, and/or cogs positioned on the implant to clasp,hold, clip, and/or otherwise interact with the replacement prostheticvalve. As another example, the implant may already be positioned in anexpanded configuration in the heart before the valve is positioned inthe same or a different procedure, on the same day or a later date. Thevalve may then pass axially through the central lumen of the implant,and be positioned in the mitral, aortic, or other valve via apercutaneous, transapical, transseptal, or other approach, some of whichare described in the present specification. The implant may thencontract around the valve, causing the hooks, clasps, tangs, clips,fasteners, and/or cogs positioned on the implant to clasp, hold, clip,and/or otherwise interact with the prosthetic replacement valve.Non-limiting examples of valves that can be delivered or modified fordelivery and anchored with the implants described herein include theFORTIS or SAPIEN valves from Edwards Lifesciences, the TIARA valve fromNeovasc, and the COREVALVE and ENGAGER valves from Medtronic, Inc.

In some embodiments, the prosthetic replacement valve may also bedelivered at the same time as the implant. For example, the valve may becoupled to the same delivery catheter (e.g., delivery catheter 301 (FIG.3)) and/or delivery system as the implant. In some cases, the valve maybe placed coaxially within the implant such that implant and valve maybe deployed at the same time. In other cases, the valve may be placedoff-axis, but still disposed within the implant's frame duringdeployment.

FIG. 32 illustrates an example replacement prosthetic heart valveoperably coupled to an example implant. Implant 3200 has been collapsedaround valve 3201. Valve 3201 is a prosthetic valve comprising anteriorleaflet 3202 and posterior leaflet 3204. Implant 3200 has a plurality ofconnectors (e.g., connector 3203) that connects implant 3200 to valve3201. Connector 3203 may be a hook, clasp, tang, clip, fastener, and/orcog positioned on implant 3200 to clasp, hold, clip, and/or otherwiseinteract with valve 3201.

Various other modifications, adaptations, and alternative designs are ofcourse possible in light of the above teachings. For example, whilegenerally described in conjunction with resizing and/or reshaping of amitral valve annulus, in some embodiments, aortic, tricuspid, pulmonic,or venous valves can also be altered using devices and methods asdisclosed herein. Other vascular and non-vascular body lumens such as,for example, the esophagus, stomach, intestines, ureters, fallopiantubes, and other lumens can also be altered using devices and methods asdisclosed herein. Therefore, it should be understood at this time thatwithin the scope of the appended claims the invention may be practicedotherwise than as specifically described herein. It is contemplated thatvarious combinations or subcombinations of the specific features andaspects of the embodiments disclosed above may be made and still fallwithin one or more of the inventions. Further, the disclosure herein ofany particular feature, aspect, method, property, characteristic,quality, attribute, element, or the like in connection with anembodiment can be used in all other embodiments set forth herein.Accordingly, it should be understood that various features and aspectsof the disclosed embodiments can be combined with or substituted for oneanother in order to form varying modes of the disclosed inventions.Thus, it is intended that the scope of the present inventions hereindisclosed should not be limited by the particular disclosed embodimentsdescribed above. Moreover, while the invention is susceptible to variousmodifications, and alternative forms, specific examples thereof havebeen shown in the drawings and are herein described in detail. It shouldbe understood, however, that the invention is not to be limited to theparticular forms or methods disclosed, but to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the various embodiments describedand the appended claims. Any methods disclosed herein need not beperformed in the order recited. The methods disclosed herein includecertain actions taken by a practitioner; however, they can also includeany third-party instruction of those actions, either expressly or byimplication. For example, actions such as “inserting an adjustablevalvular ring proximate an annulus” includes “instructing the insertingof an adjustable valvular ring proximate an annulus.” The rangesdisclosed herein also encompass any and all overlap, sub-ranges, andcombinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “approximately”, “about”, and“substantially” as used herein include the recited numbers (e.g., about10%=10%), and also represent an amount close to the stated amount thatstill performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

What is claimed is:
 1. A method of reconfiguring a mitral valve annulus, comprising: positioning an implant having a first diameter into a left atrium, the implant comprising a frame having a proximal end, a distal end, a pair of struts joined at an apex, and a plurality of anchors near the distal end; expanding the positioned implant to a second diameter larger than the first diameter; connecting the expanded implant to tissue surrounding a mitral valve by embedding the plurality of anchors into the tissue; adjusting an angle between the pair of struts to contract the implant; and positioning a restraint on the pair of struts to retain the angle.
 2. A method as in claim 1, wherein the connecting step comprises distally advancing the anchors relative to the frame.
 3. A method as in claim 1, wherein the connecting step comprises rotating the anchors.
 4. A method as in claim 1, wherein the adjusting step comprises reducing an angle between the pair of struts.
 5. A method as in claim 4, wherein the adjusting step comprises axially moving the restraint relative to the pair of struts.
 6. A method as in claim 4, wherein the adjusting step comprises rotating the restraint.
 7. A method as in claim 1, wherein the positioning a restraint step comprises retaining the angle by positioning a collar around the pair of struts to prevent the angle between the pair of struts from increasing.
 8. A method as in claim 7, wherein positioning a collar comprises rotating the collar in threaded engagement with the frame.
 9. A method as in claim 5, comprising axially distally moving the restraint relative to the pair of struts.
 10. A method as in claim 1, wherein the adjusting step comprises moving the restraint relative to the pair of struts to change a distance between two anchors.
 11. A method as in claim 10, wherein the adjusting step changes the size of the implant.
 12. A method as in claim 10, wherein the adjusting step changes the shape of the implant.
 13. A method as in claim 3, wherein the anchors move axially relative to the frame in response to rotation.
 14. A method as in claim 3, wherein the anchors comprise a helical configuration which embeds into tissue in response to rotation.
 15. A method as in claim 1, wherein the positioning step is accomplished via a femoral artery access.
 16. A method as in claim 1, wherein the positioning step is accomplished via a brachial artery access.
 17. A method as in claim 1, wherein the positioning step is accomplished via a jugular vein access.
 18. A method as in claim 1, wherein the positioning step is accomplished via a transapical access. 